Rectocele
Conditions
Keywords
Rectocele, Trans anal STARR resection, Transvaginal repair
Brief summary
The primary objective of this study is to compare the function results between two methods for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis is that the relatively new type of endo-anal surgery will result in better voiding function compared to the traditional vaginal surgery.
Interventions
PROCEDURESTARR rectocele repair
The STARR transanal stapling system is used to repair a rectocele.
PROCEDUREElevate mesh rectocele repair
A posterior Elevate mesh is placed transvaginally to repair a rectocele.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient is not under any type of guardianship * patient has a rectocele \> 3 cm during defecography * patient has persistent defecatory troubles depite medical treatment (laxatives for at least 1 month) and an ODS score \> 10 * patient recieved information and signed the consent form
Exclusion criteria
* patient cannot read French * patient has an asymptomatic rectocele * patient with an enterocele at rest upon defecography, with opacification of the small bowel * patient with non-rehabilitated anorectal asynchrony (anism) * patient with anal incontinence, Wexner score \> 7 * patient has a rectal lesion * patient has previously had rectal surgery including a colorectal anastomosis * patient has previously had a surgery involving disection of the rectovaginal wall, except for myorraphy of relever muscles * patient has previously had pelvic radiotherapy * anal sphincter insufficiency detected by rectomanometry * megarectum detected by rectomanometry and defecography * granule transit anomaly: \> 70h * exteriorized rectal prolapse * rectovaginal fistule * intestinal inflammatory disease * anal stenosis * anal or rectal tumor * patient refuses to participate or refuses to sign consent * patient is enrolled in another study * contra indication for general or localized anesthesia * patient does not have social security coverage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| presence/absence of a 50% drop in the ODS score | 12 months | presence/absence of a 50% drop in the ODS score: constipation score defined by Altomare et al, 2008. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of laxative use | 6 weeks | — |
| Intervention time (min) | 1 day | — |
| Questionnaire PFDI 20 | 6 weeks | — |
| presence/absence of prolapse recurrence | 6 weeks | presence/absence of prolapse recurrence: determined by prolapse staging |
| Questionnaire SF 36 | 6 weeks | — |
| Questionnaire PISQ-12 | 6 weeks | — |
| Questionnaire PFIQ 7 | 6 weeks | — |
Countries
France
Outcome results
None listed